RecruitingPhase 1

BBO-11818 in Adult Subjects With KRAS Mutant Cancer

United States387 participantsStarted 2025-03-31

Plain-language summary

A first in human study to evaluate the safety and preliminary antitumor activity of BBO-11818, a pan-KRAS inhibitor, in subjects with locally advanced unresectable or metastatic KRAS mutant solid tumors.

Who can participate

Age range18 Years

SexALL

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Inclusion Criteria: * Histologically documented locally advanced and unresectable or metastatic NSCLC, PDAC, CRC, or other solid tumor with KRAS G12A, G12C, G12D, G12S, or G12V mutation * Measurable disease by RECIST v1.1 * Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1 Exclusion Criteria: * Malignancy within the last 2 years as specified in the protocol * Untreated brain metastases * Known hypersensitivity to BBO-11818 or its excipients Other inclusion/exclusion criteria are specified in the protocol.

What they're measuring

Incidence and severity of treatment emergent adverse events (TEAEs), serious adverse events (SAEs), and dose-limiting toxicities (DLTs)

Timeframe: approximately 5 years

Determine recommended dose of BBO-11818 in combination with pembrolizumab +/- cis/carboplatin + pemetrexed, or cetuximab +/- FOLFOX, NALIRIFOX, or Gemcitabine + Nab-paclitaxel

Timeframe: approximately 5 years

Trial details

NCT IDNCT06917079

SponsorTheRas, Inc., d/b/a BBOT (BridgeBio Oncology Therapeutics)

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-08

Contact for this trial

TheRas, Inc., d/b/a BBOT (BridgeBio Oncology Therapeutics)

tbbo11818-101ct.gov@bbotx.com

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